Palbociclib Impurity 105 NEW

Palbociclib Impurity;1779124-68-3

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

Product Information

• Product Code：P005105

• English Name：Palbociclib Impurity 105

• English Alias：tert-butyl 4-(2-nitropyridin-3-yl)piperazine-1-carboxylate

• CAS No.：1779124-68-3

• Molecular Formula：C₁₄H₂₀N₄O₄

• Molecular Weight：308.33

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Palbociclib impurity analysis and quality control.

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-acetonitrile mixture within 6 months.

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 105 in Palbociclib API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors impurity formation during Palbociclib synthesis, reducing generation by >30% by adjusting nitration temperature (e.g., 0-5℃) and reaction time.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).

Background Description

Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 7 minutes, with LOD of 0.005 ng/mL for high-precision trace impurity analysis.

• Formation Mechanism：Formed by nitration of tert-butyl 4-(3-pyridyl)piperazine-1-carboxylate in nitric acid-sulfuric acid systems; optimizing nitrating agent ratio and reaction pH inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 198.4 μM against MCF-7 cells (Palbociclib IC₅₀=7.6 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor nitro reduction degradation under high temperature and humidity conditions

NOTE！

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!